JP5896538B2 - Prosthesis with radiopaque elements - Google Patents
Prosthesis with radiopaque elements Download PDFInfo
- Publication number
- JP5896538B2 JP5896538B2 JP2013519113A JP2013519113A JP5896538B2 JP 5896538 B2 JP5896538 B2 JP 5896538B2 JP 2013519113 A JP2013519113 A JP 2013519113A JP 2013519113 A JP2013519113 A JP 2013519113A JP 5896538 B2 JP5896538 B2 JP 5896538B2
- Authority
- JP
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- Prior art keywords
- fabric
- prosthesis
- patch
- base fabric
- radiopaque
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
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Images
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/0063—Implantable repair or support meshes, e.g. hernia meshes
-
- D—TEXTILES; PAPER
- D04—BRAIDING; LACE-MAKING; KNITTING; TRIMMINGS; NON-WOVEN FABRICS
- D04B—KNITTING
- D04B21/00—Warp knitting processes for the production of fabrics or articles not dependent on the use of particular machines; Fabrics or articles defined by such processes
- D04B21/10—Open-work fabrics
- D04B21/12—Open-work fabrics characterised by thread material
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/0004—Closure means for urethra or rectum, i.e. anti-incontinence devices or support slings against pelvic prolapse
- A61F2/0031—Closure means for urethra or rectum, i.e. anti-incontinence devices or support slings against pelvic prolapse for constricting the lumen; Support slings for the urethra
- A61F2/0036—Closure means for urethra or rectum, i.e. anti-incontinence devices or support slings against pelvic prolapse for constricting the lumen; Support slings for the urethra implantable
- A61F2/0045—Support slings
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2210/00—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
- A61F2210/0004—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof bioabsorbable
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
- A61F2250/0058—Additional features; Implant or prostheses properties not otherwise provided for
- A61F2250/006—Additional features; Implant or prostheses properties not otherwise provided for modular
- A61F2250/0062—Kits of prosthetic parts to be assembled in various combinations for forming different prostheses
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
- A61F2250/0058—Additional features; Implant or prostheses properties not otherwise provided for
- A61F2250/0085—Identification means; Administration of patients
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
- A61F2250/0058—Additional features; Implant or prostheses properties not otherwise provided for
- A61F2250/0096—Markers and sensors for detecting a position or changes of a position of an implant, e.g. RF sensors, ultrasound markers
- A61F2250/0097—Visible markings, e.g. indicia
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
- A61F2250/0058—Additional features; Implant or prostheses properties not otherwise provided for
- A61F2250/0096—Markers and sensors for detecting a position or changes of a position of an implant, e.g. RF sensors, ultrasound markers
- A61F2250/0098—Markers and sensors for detecting a position or changes of a position of an implant, e.g. RF sensors, ultrasound markers radio-opaque, e.g. radio-opaque markers
-
- D—TEXTILES; PAPER
- D10—INDEXING SCHEME ASSOCIATED WITH SUBLASSES OF SECTION D, RELATING TO TEXTILES
- D10B—INDEXING SCHEME ASSOCIATED WITH SUBLASSES OF SECTION D, RELATING TO TEXTILES
- D10B2403/00—Details of fabric structure established in the fabric forming process
- D10B2403/02—Cross-sectional features
- D10B2403/021—Lofty fabric with equidistantly spaced front and back plies, e.g. spacer fabrics
- D10B2403/0213—Lofty fabric with equidistantly spaced front and back plies, e.g. spacer fabrics with apertures, e.g. with one or more mesh fabric plies
-
- D—TEXTILES; PAPER
- D10—INDEXING SCHEME ASSOCIATED WITH SUBLASSES OF SECTION D, RELATING TO TEXTILES
- D10B—INDEXING SCHEME ASSOCIATED WITH SUBLASSES OF SECTION D, RELATING TO TEXTILES
- D10B2501/00—Wearing apparel
- D10B2501/06—Details of garments
- D10B2501/063—Fasteners
- D10B2501/0632—Fasteners of the touch-and-close type
-
- D—TEXTILES; PAPER
- D10—INDEXING SCHEME ASSOCIATED WITH SUBLASSES OF SECTION D, RELATING TO TEXTILES
- D10B—INDEXING SCHEME ASSOCIATED WITH SUBLASSES OF SECTION D, RELATING TO TEXTILES
- D10B2509/00—Medical; Hygiene
- D10B2509/08—Hernia repair mesh
Landscapes
- Health & Medical Sciences (AREA)
- Engineering & Computer Science (AREA)
- Vascular Medicine (AREA)
- Life Sciences & Earth Sciences (AREA)
- Oral & Maxillofacial Surgery (AREA)
- Transplantation (AREA)
- Biomedical Technology (AREA)
- Heart & Thoracic Surgery (AREA)
- Veterinary Medicine (AREA)
- Cardiology (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Textile Engineering (AREA)
- Prostheses (AREA)
- Materials For Medical Uses (AREA)
Description
本発明は、生地を基にし、外科医のための情報手段を備え、指定された配置におけるプロテーゼの埋込を促進し、および/または埋め込まれると、放射線透視によって、プロテーゼの位置を判定するように設計される、プロテーゼに関する。 The present invention is based on a fabric, comprises information means for the surgeon, facilitates the implantation of the prosthesis in a specified configuration, and / or, when implanted, determines the position of the prosthesis by radioscopy. The prosthesis is designed.
例えば、腹壁補強材または尿失禁パッド等の多くのプロテーゼは、例えば、膜の形態のコーティング、補強要素、一式の針等、付加的要素を随伴してもよく、またはそうでなくてもよい、生体適合性生地片の形態をとる。これらのプロテーゼの生地片は、多くの場合、対称形状である。これは、特に、壁、例えば、腹壁を補強するためのプロテーゼの場合に該当し、これらは、外科手術分野において広範に使用され、一時的にまたは絶対的に、組織損傷を充填することによって、ヘルニアを治療するために設計されている。これらのプロテーゼは、適応する必要がある、解剖学的構造に応じて、種々の形状:長方形、丸形、卵形等であってもよい。これらのプロテーゼのいくつかは、全体的に、生体分解性糸から作製され、細胞定着が生じ、組織再寄生が引き継がれるまで、その補強役割を果たした後、消失するよう意図される。他のプロテーゼは、非生体分解性糸を備え、患者の身体に恒久的に残留するように意図される。 For example, many prostheses such as abdominal wall reinforcements or urinary incontinence pads may or may not be accompanied by additional elements such as coatings in the form of membranes, reinforcing elements, a set of needles, etc. It takes the form of a biocompatible dough piece. The fabric pieces of these prostheses are often symmetrical. This is especially true in the case of prostheses for reinforcing walls, such as the abdominal wall, which are widely used in the surgical field, by temporarily or absolutely filling tissue damage, Designed to treat hernias. These prostheses may be of various shapes: rectangular, round, oval, etc., depending on the anatomy that needs to be adapted. Some of these prostheses are made entirely from biodegradable yarns and are intended to disappear after fulfilling their reinforcing role until cell colonization occurs and tissue reinfestation is taken over. Other prostheses comprise non-biodegradable threads and are intended to remain permanently on the patient's body.
いずれの場合も、安全上の理由から、これらのプロテーゼは、多くの場合、埋込時、周囲器官に対して、具体的かつ非常に精密な方法において、位置付けられなければならない。したがって、時として、これらのプロテーゼは、特に、プロテーゼが埋め込まれると、プロテーゼの位置に関する指標を外科医に提供する目的のために、マーカまたは情報手段を具備することが必要である。 In any case, for safety reasons, these prostheses often have to be positioned in a specific and very precise manner relative to the surrounding organs at the time of implantation. Thus, at times, these prostheses need to be provided with markers or information means for the purpose of providing the surgeon with an indication regarding the position of the prosthesis, particularly when the prosthesis is implanted.
したがって、埋込部位の環境に応じて、例えば、内蔵、軟組織等の存在下、生地片を特定の配向に位置付ける、またはプロテーゼのある領域を器官に面するように、または対照的に、可能な限り、器官から離れるように等、位置付けることができるように、外科医に、生地上の所定の場所に指標を与えることが重要となり得る。 Thus, depending on the environment of the implantation site, for example, in the presence of visceral, soft tissue, etc., the fabric piece can be positioned in a specific orientation, or the area with the prosthesis can be facing the organ, or in contrast As far as it can be positioned, such as away from the organ, it may be important to give the surgeon an index in place on the fabric.
埋め込まれたプロテーゼの位置を識別可能にするために、プロテーゼが具備する放射線不透過性要素は、続いて、放射線透視によって、監視可能であるよう使用される。用語「放射線不透過性要素」とは、本発明によると、X線または電離放射線によって透過されず、放射線撮影または放射線透視によって見ることができる、不透過性要素を意味するように理解される。 In order to be able to identify the position of the implanted prosthesis, the radiopaque element provided by the prosthesis is subsequently used to be monitored by radioscopy. The term “radiopaque element” is understood according to the invention to mean an opaque element that is not transmitted by X-rays or ionizing radiation and can be viewed by radiography or radioscopy.
しかしながら、プロテーゼに放射線不透過性要素を提供することは、安心ではない。最大限の範囲において、患者の身体内における放射線不透過性物質の存在を最小限にする目的のために、外科医が、プロテーゼ内に導入することを所望する放射線不透過性要素の量およびプロテーゼ上の点を決定可能であることが望ましいであろう。外科医が、容易かつ迅速に、例えば、埋込直前に、プロテーゼに、1つ以上の放射線不透過性要素を提供するための手段を有することが有利となるであろう。 However, providing a radiopaque element to the prosthesis is not secure. To the maximum extent, the amount of radiopaque element the surgeon wishes to introduce into the prosthesis and on the prosthesis for the purpose of minimizing the presence of radiopaque material in the patient's body. It would be desirable to be able to determine this point. It would be advantageous for the surgeon to have means for providing one or more radiopaque elements to the prosthesis easily and quickly, eg, just prior to implantation.
したがって、放射線不透過性要素およびプロテーゼ自体の両方の有効性を脅かすことなく、確実かつ迅速に、プロテーゼの生地に、放射線不透過性要素を提供可能である必要性が残留する。 Thus, there remains a need to be able to provide a radiopaque element to the fabric of the prosthesis reliably and quickly without compromising the effectiveness of both the radiopaque element and the prosthesis itself.
本発明の目的は、生地上に搭載しやすい放射線不透過性要素を具備し、プロテーゼの位置付けおよびその有効性に何ら負の影響を及ぼさない、生地を基にする、プロテーゼを提供することによって、本必要性を充足させることである。 The object of the present invention is to provide a fabric-based prosthesis comprising a radiopaque element that is easy to mount on the fabric and has no negative impact on the positioning of the prosthesis and its effectiveness. To satisfy this need.
本発明の第1の側面は、i)少なくとも1つの開口付き表面を有する、ベース生地と呼ばれる少なくとも1つの生地と、ii)少なくとも1つのパッチであって、その表面の1つから突出し、表面の具体的場所において、パッチをベース生地の開口付き表面に把持するように締結する、少なくとも1つの棘を具備し、少なくとも1つの放射線不透過性要素を備える、パッチと、を備える、埋込部位に埋め込まれることが意図される、プロテーゼである。 A first aspect of the present invention is: i) at least one fabric called base fabric having at least one apertured surface; and ii) at least one patch, protruding from one of the surfaces, At a specific location, the patch comprising at least one barb and at least one radiopaque element that fastens the patch to be clamped to the open surface of the base fabric. A prosthesis that is intended to be implanted.
用語「生地」とは、本願の文脈では、編成、織成、編組、または不織生地等、2つの対向表面を有する、生体適合性糸、繊維、モノフィラメントおよび/またはマルチフィラメントの配列またはアセンブリによって得られる、任意の生地を意味するように理解される。 The term “fabric” in the context of the present application is by an array or assembly of biocompatible yarns, fibers, monofilaments and / or multifilaments having two opposing surfaces, such as knitted, woven, braided or non-woven fabrics. It is understood to mean any dough obtained.
本発明による、プロテーゼのベース生地の表面のうちの少なくとも1つは、開口付きである。用語「開口付き表面」とは、本願によると、生地の表面が、外部に開放される、開口部、空洞、空隙、または孔を備えることを意味するように理解される。そのような開口部は、生地内への細胞の貫入、したがって、埋込後、プロテーゼの細胞再定着を促進する。後述の説明から明白となるように、本発明による、プロテーゼのベース生地の開口付き表面内の開口部は、生地を構成する糸によって形成される壁によって、本発明による、プロテーゼのパッチまたは複数のパッチの棘または複数の棘を受容および保定可能にするサイズを有する。 At least one of the surfaces of the base fabric of the prosthesis according to the invention is apertured. The term “open surface” is understood according to the present application to mean that the surface of the dough is provided with openings, cavities, voids or holes that are open to the outside. Such an opening facilitates the penetration of cells into the dough and thus the cell re-establishment of the prosthesis after implantation. As will become apparent from the following description, the opening in the open surface of the base fabric of the prosthesis according to the present invention is a patch of the prosthesis or a plurality of The patch has a size that allows it to receive and retain a barb or multiple barbs.
本発明による、プロテーゼは、特に、単純かつ迅速に、生成され得る。具体的には、プロテーゼのベース生地は、放射線不透過性要素を含めるために、任意の特定の処理を受ける必要はない。例えば、少なくとも1つの放射線不透過性糸を備え、患者内に埋め込まれると、プロテーゼの放射線透視画像を撮影することによって、プロテーゼの位置に関する好適な情報を外科医に提供する、特定の場所において、ベース生地に把持するように締結される、把持性生地から製造され得る、1つ以上のパッチを、生地に具備するだけで十分である。 The prosthesis according to the invention can be produced in particular simply and quickly. In particular, the base fabric of the prosthesis need not be subjected to any particular treatment to include a radiopaque element. For example, a base at a particular location comprising at least one radiopaque thread and providing a surgeon with suitable information regarding the location of the prosthesis by taking a fluoroscopic image of the prosthesis when implanted in a patient. It is sufficient to provide the fabric with one or more patches that can be manufactured from a gripping fabric that is fastened to grip the fabric.
本発明による、プロテーゼは、放射線不透過性要素を具備するが、ベース生地の初期特性のいずれも喪失しない。特に、パッチが、放射線不透過性糸を備える、開口付き把持性生地から作製される時、本発明による、プロテーゼのベース生地の開口付き表面は、その良好な細胞再定着能力を維持する。 The prosthesis according to the present invention comprises a radiopaque element but does not lose any of the initial properties of the base fabric. In particular, when the patch is made from an open gripping fabric comprising a radiopaque yarn, the open surface of the base fabric of the prosthesis according to the present invention maintains its good cell re-fixation ability.
本発明による、プロテーゼは、前述のように、複数のパッチを備えてもよく、これらは、ベース生地の開口付き表面上の具体的場所において、把持するように締結される。 The prosthesis according to the present invention may comprise a plurality of patches, as described above, which are fastened to grip at specific locations on the open surface of the base fabric.
したがって、長方形または正方形ベース生地の場合、外科医は、移植されると、プロテーゼ全体の位置をより容易に判定可能となるように、生地の各隅にパッチを留置してもよく、例えば、埋込直後に生成された第1の術後放射線透視画像、次いで、例えば、埋込から数カ月後、1つ以上の他の放射線透視画像を撮影することによって、種々の放射線透視画像間の比較によって、外科医は、プロテーゼが移動していないかどうか、または、例えば、ベース生地の縮小または収縮によって、変形されていないかどうか確認可能となる。 Thus, in the case of a rectangular or square base fabric, the surgeon may place a patch at each corner of the fabric so that once implanted, the location of the entire prosthesis can be more easily determined, for example, implanted A surgeon can compare the various radioscopy images by taking a first postoperative radioscopy image generated immediately afterwards, and then one or more other radioscopy images, for example, months after implantation. Can be confirmed whether the prosthesis has not moved or has been deformed, for example, by shrinking or shrinking the base fabric.
本発明による、プロテーゼのベース生地は、開口付きのその2つの表面を有してもよい。そのような場合、1つ以上のパッチは、生地の2つの表面のそれぞれに把持するように締結され、そのような構成は、プロテーゼの厚さを、したがって、例えば、埋込から数週間または数カ月後、その完全性の状態を放射線透視的に判定可能にしてもよい。 The base fabric of the prosthesis according to the invention may have its two surfaces with openings. In such a case, one or more patches are fastened to grip on each of the two surfaces of the fabric, such a configuration can increase the thickness of the prosthesis and thus, for example, weeks or months after implantation Later, the state of integrity may be made radioscopically determinable.
本発明による、プロテーゼのベース生地は、織布、不織布、編組、編成、または後者の組み合わせ等、生体適合性糸、フィラメント、または繊維を基にした任意の生地であってもよいが、その表面のうちの少なくとも1つは、開口付きである。 The base fabric of the prosthesis according to the present invention may be any fabric based on biocompatible yarns, filaments or fibers, such as woven fabric, non-woven fabric, braided, knitted, or a combination of the latter, but on its surface At least one of them has an opening.
本発明による、ベース生地を形成する、糸、繊維、あるいはフィラメントおよび/またはマルチフィラメントは、生体分解性であるかどうかを問わず、任意の生体適合性材料から作製されてもよい。 The yarns, fibers, or filaments and / or multifilaments that form the base fabric according to the present invention may be made from any biocompatible material, whether biodegradable or not.
用語「生体分解性」または「生体吸収性」とは、本願の文脈では、材料が、生物学的組織によって吸収および分解され、材料の化学的性質に応じて、例えば、数時間から数カ月後に及び得る、指定された時間周期後、生体内で消失する、特色を意味するように理解される。 The term “biodegradable” or “bioabsorbable” means in the context of the present application that the material is absorbed and degraded by biological tissue, depending on the chemical nature of the material, for example after several hours to several months. Obtained is understood to mean a feature that disappears in vivo after a specified period of time.
したがって、本発明のベース生地の糸に好適な生体分解性材料は、ポリ乳酸(PLA)、ポリグリコール酸(PGA)、酸化セルロース、キトサン、ポリホスファゼン、ポリカプロラクトン(PCL)、ポリジオキサノン(PDO)、トリメチレンカーボネート(TMC)、ポリビニルアルコール(PVA)、ポリヒドロキシアルカノエート(PHA)、ポリアミド、ポリエーテル、それらのコポリマー、およびそれらの混成物から選択されてもよい。本発明のベース生地の糸に好適な非生体分解性材料は、テレフタル酸ポリエチレン(PET)、ポリアミド、アラミド、膨張ポリテトラフルオロエチレン、ポリウレタン、ポリフッ化ビニリデン(PVDF)、ブチルエステルポリマー、PEEK(ポリエーテルエーテルケトン)、ポリオレフィン(ポリエチレンまたはポリプロピレン等)、銅合金、銀または白金合金、医療等級のステンレス鋼等の医療等級の鋼鉄、およびそれらの組み合わせから選択されてもよい。 Therefore, suitable biodegradable materials for the yarn of the base fabric of the present invention are polylactic acid (PLA), polyglycolic acid (PGA), oxidized cellulose, chitosan, polyphosphazene, polycaprolactone (PCL), polydioxanone (PDO), It may be selected from trimethylene carbonate (TMC), polyvinyl alcohol (PVA), polyhydroxyalkanoate (PHA), polyamide, polyether, copolymers thereof, and hybrids thereof. Non-biodegradable materials suitable for the base fabric yarn of the present invention include polyethylene terephthalate (PET), polyamide, aramid, expanded polytetrafluoroethylene, polyurethane, polyvinylidene fluoride (PVDF), butyl ester polymer, PEEK (polyethylene). Ether ether ketone), polyolefins (such as polyethylene or polypropylene), copper alloys, silver or platinum alloys, medical grade steels such as medical grade stainless steel, and combinations thereof.
本発明の一実施形態では、ベース生地は、編地である。編地は、編地を構成する、メッシュのため、特に、本発明による、プロテーゼに好適である、開口付き表面を提供する。編地は、2次元または3次元であってもよい。 In one embodiment of the present invention, the base fabric is a knitted fabric. The knitted fabric provides an open surface that is suitable for the prosthesis according to the present invention because of the mesh that constitutes the knitted fabric. The knitted fabric may be two-dimensional or three-dimensional.
用語「2次元編地」は、本願の文脈では、メッシュによってともに連結された2つの対向表面を有するが、ある厚さをもたらすスペーサを欠いている、編地であることを意味するように理解される。そのような編地は、例えば、2つの針ガイドバーを使用して、縦編またはラッセル編機上において、糸を編成することによって、得られてもよい。少なくとも1つの開口付き表面を伴う、本発明に好適な2次元編地を編成する実施例は、第WO2009/071998号に与えられている。 The term “two-dimensional knitted fabric” is understood in the context of the present application to mean a knitted fabric that has two opposing surfaces joined together by a mesh, but lacks a spacer that provides a certain thickness. Is done. Such a knitted fabric may be obtained, for example, by knitting the yarn on a warp or raschel knitting machine using two needle guide bars. An example of knitting a two-dimensional knitted fabric suitable for the present invention with at least one apertured surface is given in WO 2009/071998.
用語「3次元編地」は、本願によると、編地に有意な厚さを与えるスペーサによってともに連結される2つの対向表面を有し、スペーサ自体は、編地の2つの表面を形成する糸に加え、付加的連結糸から形成される、編地を意味するように理解される。そのような編地は、例えば、いくつかの針ガイドバーを使用して、ダブルベッド式縦編またはラッセル編機上で得られてもよい。少なくとも1つの開口付き表面を伴う、本発明に好適な3次元編地を編成する実施例は、第WO99/05990号、第WO2009/031035号、および第WO2009/071998号に与えられる。 The term “three-dimensional knitted fabric”, according to the present application, has two opposing surfaces joined together by a spacer that gives the knitted fabric a significant thickness, the spacer itself being a yarn that forms the two surfaces of the knitted fabric Is understood to mean a knitted fabric formed from additional connecting yarns. Such a knitted fabric may be obtained on a double bed warp or raschel knitting machine using, for example, several needle guide bars. Examples of knitting a three-dimensional knitted fabric suitable for the present invention with at least one apertured surface are given in WO99 / 06990, WO2009 / 031035, and WO2009 / 071998.
本発明のベース生地は、多孔性生地または編地、すなわち、その表面上だけではなく、その厚さ内にも、空洞、空隙、または孔を有し、これらの空洞、空隙、または孔が、生地の両側に表出するチャネルを構成可能であるものであってもよい。そのような多孔性生地は、より優れた組織統合をもたらし、細胞が、生地の内部へのアクセスを得ことが可能となり、例えば、腹壁補強を形成する。 The base fabric of the present invention has cavities, voids or holes not only on its surface but also within its thickness, i.e. these cavities, voids or pores, The channel which appears on both sides of the fabric may be configurable. Such a porous fabric provides better tissue integration, allowing cells to gain access to the interior of the fabric, for example forming an abdominal wall reinforcement.
例えば、ベース生地のパターンは、後者の厚さ内に、その2つの個別の開口付き表面上の生地の両側に表出し、生地に、例えば、「ハニカム」構造をもたらす、相互に略平行である、複数の横断空洞またはチャネルを決定してもよい。 For example, the pattern of the base fabric is exposed to both sides of the fabric on its two separate apertured surfaces within the latter thickness and is generally parallel to each other, resulting in a “honeycomb” structure, for example. A plurality of transverse cavities or channels may be determined.
本発明による、プロテーゼのパッチまたは複数のパッチは、任意の生体適合性材料から作製され、少なくとも1つの放射線不透過性要素を備えてもよい。 The prosthetic patch or patches according to the present invention may be made of any biocompatible material and may comprise at least one radiopaque element.
放射線不透過性要素は、任意の生体適合性放射線不透過性材料から作製されてもよい。特に、本発明に好適である、放射線不透過性材料の実施例は、金、パラジウム、タンタル、クロム、銀、ジルコニア、タングステン、白金、硫酸バリウム(BaSO4)、酸化ビスマス(Bi2O3)、ヨウ素および誘導生成物、ガドリニウム、アルミノケイ酸塩、生体適合性リン酸カルシウムセラミック、例えば、ヒドロキシアパタイトまたはリン酸三カルシウム、ならびにそれらの混合物である。 The radiopaque element may be made from any biocompatible radiopaque material. Examples of radiopaque materials particularly suitable for the present invention are gold, palladium, tantalum, chromium, silver, zirconia, tungsten, platinum, barium sulfate (BaSO 4 ), bismuth oxide (Bi 2 O 3 ). Iodine and derived products, gadolinium, aluminosilicates, biocompatible calcium phosphate ceramics such as hydroxyapatite or tricalcium phosphate, and mixtures thereof.
本発明による、プロテーゼのパッチまたは複数のパッチは、想像可能な任意の形状、例えば、幾何学形状、例えば、卵形、丸形、または長方形形状、あるいはグラフィカル形状、例えば、矢印または記号を有してもよい。一般に、最大限の範囲において、患者の身体内における異物の存在を最小限にする目的のために、パッチは、放射線透視によって検出可能にするために、必要な放射線不透過性要素用量に好適なサイズを有し、用量は、放射線不透過性要素のための毒性閾値用量を大きく下回ったままである。したがって、放射線不透過性要素の量は、放射線撮影のために所望の放射線不透過性に従って、調節される。 The patch or patches of the prosthesis according to the invention have any imaginable shape, e.g. geometric shape, e.g. oval, round, or rectangular shape, or graphical shape, e.g. arrows or symbols May be. In general, for the purpose of minimizing the presence of foreign bodies in the patient's body to the maximum extent, the patch is suitable for the required radiopaque element dose to be detectable by radioscopy. It has a size and the dose remains well below the toxicity threshold dose for the radiopaque element. Thus, the amount of radiopaque element is adjusted according to the radiopacity desired for radiography.
本発明による、プロテーゼのパッチまたは複数のパッチは、その表面の1つから突出する、少なくとも1つ、好ましくは、いくつかの棘を具備する。これらの棘は、表面の平面に略垂直の表面から、または代替として、表面の平面に対して傾斜した1つ以上の平面に沿って、突出してもよい。これらの棘は、開口部内に貫入し、ベース生地に向かって、パッチ上に付与される圧力のため、本発明による、プロテーゼのベース生地の開口付き表面または複数の表面の開口部を形成する糸内で相互に噛合することによって、締結手段として機能するように意図される。有利には、これらの棘はまた、パッチ上で引張することによって、引抜されてもよく、次いで、所望に応じて、本発明による、プロテーゼの製造時に、ベース生地の開口付き表面上のいずれかの場所に再位置付けすることができる。 The patch or patches of the prosthesis according to the invention comprise at least one, preferably several barbs, protruding from one of its surfaces. These barbs may protrude from a surface substantially perpendicular to the plane of the surface, or alternatively along one or more planes that are inclined relative to the plane of the surface. These barbs penetrate into the opening and, due to the pressure applied on the patch towards the base fabric, the thread forming the open surface or openings of the base fabric of the prosthesis according to the invention It is intended to function as a fastening means by meshing with each other. Advantageously, these barbs may also be withdrawn by pulling on the patch and then, if desired, either on the open surface of the base fabric during the manufacture of the prosthesis according to the invention. Can be repositioned in place.
したがって、パッチは、必要に応じて、一時的に、本発明による、プロテーゼのベース生地に把持するように締結されてもよい。したがって、一実施形態では、棘または複数の棘は、再位置付け可能に、パッチまたは複数のパッチをベース生地の開口付き表面に把持するように締結する。 Accordingly, the patch may be temporarily fastened as needed to grip onto the base fabric of the prosthesis according to the present invention. Thus, in one embodiment, the barbs or plurality of barbs are repositionably fastened to grip the patch or patches to the open surface of the base fabric.
代替として、パッチとベース生地との間に、少量の接着剤の添加または縫合糸縫製によって、絶対的に、パッチまたは複数のパッチをベース生地の開口付き表面に固定可能である。 Alternatively, the patch or patches can be absolutely fixed to the open surface of the base fabric by adding a small amount of adhesive or sewing the suture between the patch and the base fabric.
棘は、パッチの本体を形成する材料と同じであってもよく、またはそうでなくてもよい、生体適合性材料から作製される。本発明の一実施形態では、棘は、放射線不透過性材料から作製され、パッチの放射線不透過性要素を構成する。 The barbs are made from a biocompatible material that may or may not be the same material that forms the body of the patch. In one embodiment of the invention, the barbs are made from a radiopaque material and constitute the radiopaque element of the patch.
本発明による、プロテーゼのパッチは、生体適合性熱可塑性の射出成形によって、生成されてもよい。 Prosthetic patches according to the present invention may be produced by biocompatible thermoplastic injection molding.
好ましい実施形態では、本発明による、プロテーゼのパッチは、把持性生地から作製される。 In a preferred embodiment, the prosthetic patch according to the present invention is made from a gripping fabric.
本願では、用語「把持性生地」は、その表面のうちの少なくとも1つ上に、規則的または無作為に配列される複数のフックまたは棘を有し、これらは、表面に略垂直に突出し、適用される開口付き生地の表面または厚さに貫入可能である、生地を意味するように理解される。周知の把持性生地の一実施例は、「Velcro(登録商標)(R)」システムの把持性部品である。したがって、本発明による、パッチの棘は、糸、例えば、直接、パッチを形成する糸の配列から出射する、熱可塑性モノフィラメント糸から形成されてもよい。そのような生地および棘ならびにその製造プロセスは、例えば、特許出願第WO01/81667号、第DE19832634号、または特許第US6596002号および第US5254133号に説明される。 As used herein, the term “gripping fabric” has a plurality of hooks or barbs arranged regularly or randomly on at least one of its surfaces, which project substantially perpendicular to the surface, It is understood to mean a dough that can penetrate the surface or thickness of the open dough to be applied. One example of a known gripping fabric is the gripping component of the “Velcro®” system. Accordingly, patch barbs according to the present invention may be formed from yarn, eg, a thermoplastic monofilament yarn that exits directly from the array of yarns forming the patch. Such fabrics and barbs and their manufacturing processes are described, for example, in patent applications WO 01/81667, DE 198 26634, or patents US 6596002 and US 5254133.
代替として、把持性生地の棘は、任意の生体適合性材料から作製され、生地を形成する糸の配列に締結される、任意のフックであってもよく、これらのフックが、糸の配列の製造(編組、編成、織成等)の間に、生地内に組み込まれた、またはその後、取着されたかどうかは、問わない。 Alternatively, the gripping fabric barbs may be any hooks made from any biocompatible material and fastened to an array of threads that form the fabric, and these hooks are arranged in an array of threads. It does not matter whether it was incorporated into the fabric during manufacture (braiding, knitting, weaving, etc.) or subsequently attached.
好ましい実施形態では、棘は、把持性生地を編成するために使用される糸から生じる。例えば、把持性生地は、一般に、第WO01/81667号に説明されるように、モノフィラメントの重なりを備え、最初に、重なりの外側に小ループを形成し、各ループは、ループを最初に形成する熱可塑性糸の部分的融解後、重なりに垂直に突出する2つの棘を生み出してもよい。 In a preferred embodiment, the barbs arise from the yarn used to knit the gripping fabric. For example, grippable fabrics generally comprise monofilament overlap as described in WO 01/81667, initially forming small loops outside the overlap, and each loop first forming a loop. After partial melting of the thermoplastic yarn, two barbs protruding perpendicular to the overlap may be produced.
したがって、本発明による、プロテーゼのパッチを形成する把持性生地は、放射線不透過性材料から形成されるその構成糸のいくつかを含んでもよい。これらの糸は、把持性生地の棘を形成するためのもの、または把持性生地の本体を形成するためのもの、またはその2つの組み合わせであってもよい。そのような実施形態では、放射線不透過性要素は、把持性生地を形成する、1つ以上の糸から成る。 Thus, the grippable fabric forming the prosthetic patch according to the present invention may comprise some of its constituent yarns formed from a radiopaque material. These threads may be for forming the barbs of the gripping fabric, or for forming the body of the gripping fabric, or a combination of the two. In such an embodiment, the radiopaque element consists of one or more threads that form a grippable fabric.
好ましくは、棘の長さは、好ましくは、限定的に、すなわち、可能であれば、ベース生地の片側から他側に通過させずに、ベース生地の開口付き表面内に貫入し、その上に捕捉するように画定される。 Preferably, the length of the barbs is preferably limited, i.e., if possible, without passing from one side of the base fabric to the other, penetrating into the open surface of the base fabric and above it Defined to capture.
放射線不透過性要素を具備する、本発明による、プロテーゼは、したがって、埋込手技を行う直前に、外科医自身によって、手術部位上において、非常に容易に生成される。 A prosthesis according to the present invention comprising a radiopaque element is therefore very easily generated on the surgical site by the surgeon himself immediately before performing the implantation procedure.
例えば、外科医が、放射線不透過性要素を備える、パッチを、その棘によって、所望の場所に、ベース生地を把持させることが、十分である。さらに、また、外科医が、それらを締結した時に、失敗した場合、把持するように締結された後、これらのパッチを除去し、次いで、最初により好適な場所に再締結させることも容易である。 For example, it is sufficient for the surgeon to have a patch comprising a radiopaque element grip the base fabric at the desired location with its barbs. Furthermore, it is also easy for the surgeon to remove these patches after being fastened to grip if they fail when they are fastened, and then refasten them first to a more suitable location.
好ましい実施形態では、使用される把持性生地自体、前述のように、開口付きおよび/または多孔性である。したがって、パッチが、ベース生地の開口付き表面に把持するように締結されると、ベース生地の開口付き表面内の開口部を全く閉塞せず、それによって、その良好な細胞再定着能力を留保する。例えば、パッチの生地構造は、棘を有するものを含む、その2つの表面上に、例えば、直径0.4から5mmを有する、開放空隙を備えるまたは画定する。一実施形態では、パッチは、その両表面上に棘を具備してもよい。 In a preferred embodiment, the gripping fabric used is itself open and / or porous as described above. Thus, when the patch is fastened to grip on the open surface of the base fabric, it does not occlude any openings in the open surface of the base fabric, thereby retaining its good cell re-fixation ability. . For example, the fabric structure of the patch comprises or defines an open void on its two surfaces, including those having barbs, for example having a diameter of 0.4 to 5 mm. In one embodiment, the patch may comprise barbs on both surfaces thereof.
本発明の一実施形態では、パッチは、第WO01/81667号に説明されるように、把持性生地から作製され、放射線不透過性材料から作製される、その構成糸のうちの少なくとも1つを備える。特に、本発明による、プロテーゼのパッチを生成するために好適である、放射線不透過性材料から作製される糸の実施例は、例えば、第US7465489号に説明されるものである。 In one embodiment of the invention, the patch comprises at least one of its constituent yarns made from a grippable fabric and made from a radiopaque material, as described in WO 01/81667. Prepare. In particular, examples of yarns made from radiopaque materials that are suitable for producing prosthetic patches according to the present invention are described, for example, in US Pat. No. 7,645,489.
例えば、各棘は、長さ1から2mmを有してもよく、棘密度は、平方センチメートルあたり30から50個の棘の範囲であってもよい。そのような密度は、パッチをベース生地に把持するように締結させ、および/または、要求に応じて、再位置付けされるように、そこから容易に除去可能にする。 For example, each barb may have a length of 1 to 2 mm and the barb density may range from 30 to 50 barbs per square centimeter. Such density allows the patch to be clamped to the base fabric and / or easily removed from it to be repositioned as required.
代替として、または組み合わせて、放射線不透過性要素は、パッチの少なくとも一方の表面上に蒸着される、放射線不透過性材料から作製されるコーティングの形態をとってもよい。例えば、パッチの少なくとも一方の表面をコーティング可能であって、これが、前述のような放射線不透過性化合物、特に、金、パラジウム、タンタル、クロム、銀、ジルコニア、およびそれらの混合物から選択されるものの化学蒸着(CVD)または可能性としてプラズマ増強化学蒸着(PECVD)による放射線不透過性コーティングを伴う、把持性生地から作製されるかどうかは、問わない。 Alternatively or in combination, the radiopaque element may take the form of a coating made from a radiopaque material deposited on at least one surface of the patch. For example, at least one surface of the patch can be coated, which is selected from radiopaque compounds as described above, particularly gold, palladium, tantalum, chromium, silver, zirconia, and mixtures thereof. It does not matter whether it is made from a gripping fabric with a radiopaque coating by chemical vapor deposition (CVD) or possibly plasma enhanced chemical vapor deposition (PECVD).
一実施形態では、放射線不透過性要素は、プラズマ増強化学蒸着によって、パッチの各表面上に蒸着された放射線不透過性材料、例えば、金から作製される、コーティングの形態である。 In one embodiment, the radiopaque element is in the form of a coating made from a radiopaque material, such as gold, deposited on each surface of the patch by plasma enhanced chemical vapor deposition.
別の実施形態では、放射線不透過性要素は、マトリクス、例えば、ポリプロピレンマトリクス内に含浸され、パッチの一方の表面に接合される、膜を形成してもよい。 In another embodiment, the radiopaque element may form a membrane that is impregnated into a matrix, eg, a polypropylene matrix, and bonded to one surface of the patch.
パッチの形態におけるそのような把持性生地が、適用されると、棘が、ベース生地の開口付き表面上において、正面に現れ、棘は、メッシュ内およびベース生地の糸間に係合し、パッチをベース生地の開口付き表面上に係止させる。本係止効果は、液体媒体内においても有効であって、パッチをベース生地に固定するために十分である一方、依然として、要求に応じて、ベース生地に対して、その位置を調節するように、パッチを締結解除可能にする。 When such a gripping fabric in the form of a patch is applied, the barbs appear on the front on the open surface of the base fabric, the barbs engage in the mesh and between the threads of the base fabric, and the patch On the open surface of the base fabric. This locking effect is also effective in the liquid medium and is sufficient to fix the patch to the base fabric, while still adjusting its position relative to the base fabric as required. The patch can be released.
本発明の別の側面は、
前述のように、埋込部位に埋め込まれるように設計される、ベース生地と呼ばれ、少なくとも1つの開口付き表面を有する、少なくとも1つの生地と、
少なくとも1つのパッチであって、その表面の1つから突出し、少なくとも1つの放射線不透過性要素を備える、少なくとも1つの棘を具備し、棘または複数の棘が、表面の具体的場所において、パッチをベース生地の開口付き表面に把持するように締結するために設計される、パッチと
を備える、キットである。本発明による、キットのパッチは、前述のようなものであってもよい。本発明による、キットは、前述のような複数のパッチを備えてもよい。
例えば、本発明は、以下の項目を提供する。
(項目1)
i)少なくとも1つの開口付き表面(3)を有する、ベース生地(2)と呼ばれる少なくとも1つの生地と、ii)少なくとも1つのパッチ(4)であって、その表面のうちの1つから突出し、前記表面上の具体的場所において、前記パッチを前記ベース生地の開口付き表面に把持するように締結する少なくとも1つの棘(5)を具備し、少なくとも1つの放射線不透過性要素を備える、パッチと、を備える、埋込部位に埋め込まれることが意図される、プロテーゼ(10)。
(項目2)
前記プロテーゼは、それぞれ、少なくとも1つの放射線不透過性要素を備える、複数のパッチ(4)を備え、前記パッチは、前記ベース生地の開口付き表面上の具体的場所において、把持するように締結されることを特徴とする、項目1に記載のプロテーゼ(10)。
(項目3)
前記ベース生地は、2つの開口付き表面を有し、1つ以上のパッチは、前記2つの開口付き表面のそれぞれに把持するように締結されることを特徴とする、項目1または2に記載のプロテーゼ(10)。
(項目4)
前記ベース生地は、編地であることを特徴とする、項目1から3のいずれかに記載のプロテーゼ(10)。
(項目5)
前記棘は、放射線不透過性材料から作製され、前記パッチの放射線不透過性要素を構成することを特徴とする、項目1から4のいずれかに記載のプロテーゼ(10)。
(項目6)
前記パッチまたは複数のパッチは、把持性生地から作製されることを特徴とする、項目1から5のいずれかに記載のプロテーゼ(10)。
(項目7)
前記放射線不透過性要素は、前記把持性生地を形成する、1つ以上の放射線不透過性糸から成ることを特徴とする、項目6に記載のプロテーゼ。
(項目8)
前記把持性生地は、開口付きであることを特徴とする、項目6または7に記載のプロテーゼ(10)。
(項目9)
前記放射線不透過性要素は、前記パッチの少なくとも一方の表面上に蒸着される、放射線不透過性材料から作製されたコーティングの形態であることを特徴とする、項目1から8いずれかに記載のプロテーゼ。
(項目10)
前記放射線不透過性要素は、プラズマ増強化学蒸着によって、前記パッチの表面のそれぞれ上に蒸着される、放射線不透過性材料から作製されたコーティングの形態であることを特徴とする、項目1から9のいずれかに記載のプロテーゼ。
(項目11)
ベース生地(2)と呼ばれ、項目1から7のいずれかに従って画定される、埋込部位に埋め込まれるように設計される、少なくとも1つの開口付き表面(3)を有する、少なくとも1つの生地と、
少なくとも1つのパッチ(4)であって、その表面のうちの1つから突出し、少なくとも1つの放射線不透過性要素を備える、少なくとも1つの棘(5)を具備し、前記棘または複数の棘は、前記表面上の具体的場所において、前記パッチを前記ベース生地の開口付き表面に把持するように締結するように設計される、パッチと
を備える、キット(1)。
Another aspect of the present invention is:
As described above, at least one fabric, referred to as a base fabric, which is designed to be embedded in an implantation site and having at least one open surface;
At least one patch, comprising at least one barb protruding from one of its surfaces and comprising at least one radiopaque element, wherein the barb or plurality of barbs at a specific location on the surface And a patch designed to fasten to a base fabric with an apertured surface. The patch of the kit according to the present invention may be as described above. The kit according to the present invention may comprise a plurality of patches as described above.
For example, the present invention provides the following items.
(Item 1)
i) at least one fabric called base fabric (2) having at least one apertured surface (3); and ii) at least one patch (4), protruding from one of the surfaces; A patch comprising at least one barb (5) for fastening the patch to an open surface of the base fabric at a specific location on the surface and comprising at least one radiopaque element; A prosthesis (10) intended to be implanted at an implantation site.
(Item 2)
The prosthesis comprises a plurality of patches (4) each comprising at least one radiopaque element, the patches being fastened to grip at a specific location on the open surface of the base fabric. The prosthesis (10) according to item 1, characterized in that:
(Item 3)
Item 1. or Item 2, wherein the base fabric has two apertured surfaces, and one or more patches are fastened to grip each of the two apertured surfaces. Prosthesis (10).
(Item 4)
The prosthesis (10) according to any one of items 1 to 3, wherein the base fabric is a knitted fabric.
(Item 5)
Prosthesis (10) according to any of items 1 to 4, characterized in that the barbs are made of a radiopaque material and constitute a radiopaque element of the patch.
(Item 6)
6. Prosthesis (10) according to any of items 1 to 5, characterized in that the patch or the plurality of patches are made from a gripping fabric.
(Item 7)
Prosthesis according to item 6, characterized in that the radiopaque element consists of one or more radiopaque yarns forming the gripping fabric.
(Item 8)
8. Prosthesis (10) according to item 6 or 7, characterized in that the gripping dough has an opening.
(Item 9)
Item 9. The item according to any of items 1 to 8, characterized in that the radiopaque element is in the form of a coating made from a radiopaque material deposited on at least one surface of the patch. Prosthesis.
(Item 10)
Items 1 to 9 characterized in that the radiopaque element is in the form of a coating made from a radiopaque material deposited by plasma enhanced chemical vapor deposition on each of the surfaces of the patch. A prosthesis according to any of the above.
(Item 11)
At least one fabric having at least one open surface (3), designed to be embedded in an implantation site, referred to as base fabric (2) and defined according to any of items 1 to 7; ,
At least one patch (4) comprising at least one barb (5) protruding from one of its surfaces and comprising at least one radiopaque element, said barb or spines being A patch designed to fasten the patch to a gripped surface of the base fabric at a specific location on the surface; and
A kit (1) comprising:
本発明の利点は、以下の説明および添付の図面に照らして、より明確に明白となるであろう。
図1を有用に参照すると、本発明による、キットは、概して、参照番号1によって示される。キット1は、長方形の全体形状の生地片2の形態である、ベース生地を備える。本生地片2は、面積4から1600cm2を有してもよく、有利には、腹壁ヘルニアを修復するために使用されてもよい。生地片2は、2つの表面を有し、その開口付き表面3が、図において視認可能である。 Referring usefully to FIG. 1, a kit according to the present invention is generally indicated by reference numeral 1. The kit 1 comprises a base fabric which is in the form of a rectangular overall shaped fabric piece 2. The fabric piece 2 may have an area of 4 to 1600 cm 2 and may advantageously be used to repair an abdominal wall hernia. The dough piece 2 has two surfaces, and the surface 3 with the opening is visible in the figure.
少なくとも1つの開口付き表面を伴う、そのような生地は、以下の方法を使用して、得られてもよい。3次元編地は、ISO11676に従って、以下の方式を使用して、テレフタル酸ポリエチレン(PET)マルチフィラメント糸(50デシテックス(dtex);22フィラメント)が、1つはフル/1つは空の状態において通された6つの針ガイドバーを使用して、22-ゲージラッセル編機上で生成される。
バー1:1.2.1.1/1.0.1.1/1.2.1.1/1.0.1.1/1.2.2.2/3.2.2.2/1.2.2.2/3.2.2.2//
バー2:1.2.2.2/3.2.2.2/1.2.2.2/3.2.2.2/1.2.1.1/1.0.1.1/1.2.1.1/1.0.1.1//
バー3:0.1.0.1/0.0.0.0//
バー4:0.1.0.1/0.0.0.0//
バー5:1.1.0.1/1.1.2.1/1.1.0.1/1.1.2.1/2.2.2.3/2.2.2.1/2.2.2.3/2.2.2.1//
バー6:2.2.2.3/2.2.2.1/2.2.2.3/2.2.2.1/1.1.0.1/1.1.2.1/1.1.0.1/1.1.2.1//
バー1および2は、生地の一方の表面を形成し、バー5および6は、生地の反対表面を形成し、バー3および4は、2つの表面をともに連有するスペーサを形成する。
Such a fabric with at least one apertured surface may be obtained using the following method. The three-dimensional knitted fabric is in accordance with ISO 11676 using the following method: Polyethylene terephthalate (PET) multifilament yarn (50 dtex; 22 filaments), one full / one empty It is produced on a 22-gauge Russell knitting machine using a threaded six needle guide bar.
Bar 1: 1.2.1.1/1.0.1.1/1.2.1.1/1.0.1.1/1.2.2.2/3.2.2.2 /1.2.2.2/3.2.2.2//
Bar 2: 1.2.2.2/3.2.2.2/1.2.2.2/3.2.2.2/1.2.1.1/1.0.1.1 /1.2.1.1/1.0.1.1//
Bar 3: 0.1.0.1/0.0.0.0//
Bar 4: 0.1.0.1/0.0.0.0//
Bar 5: 1.1.0.1/1.1.2.1/1.1.0.1/1.1.2.2.1/2.2.2.2.3/2.2.2.1 /2.2.2.3/2.2.2.1//
Bar 6: 2.2.2.3/2.2.2.1/2.2.2.3/2.2.2.1/1.1.0.1/1.1.2.1 /1.1.0.1/1.1.2.1//
Bars 1 and 2 form one surface of the fabric, bars 5 and 6 form the opposite surface of the fabric, and bars 3 and 4 form a spacer that links the two surfaces together.
そのような構造は、その両表面上に約2.5×1.7の開口部を有する、3次元編地をもたらす。 Such a structure results in a three-dimensional knitted fabric having approximately 2.5 × 1.7 openings on both surfaces thereof.
図1はまた、それぞれ、全体的に円盤形態をとる、4つのパッチ4を示す。これらのパッチはそれぞれ、パッチ4の断面図である、図2に示されるように、その表面の一方に垂直に突出する、棘5を具備する。 FIG. 1 also shows four patches 4 each taking the form of a disk overall. Each of these patches comprises barbs 5 that project perpendicularly to one of its surfaces, as shown in FIG.
本実施例では、パッチ4は、以下の様式で得られた把持性生地から作製される。編地は、3つの針ガイドバーを使用して、24-ゲージ横編機上で生成される。バー1および2は、把持性生地の本体を形成するように意図され、0.09mm径テレフタル酸ポリエチレン(PET)モノフィラメント糸が、ISO11676に従って、以下の方式によって、1つはフル/1つは空の状態において通される。
バー1:1.0/0.1//
バー2:4.5/1.0//.
バー3は、モノフィラメントの重なりを形成し、棘をもたらすように意図され、0.15mm径ポリ乳酸(PLA)モノフィラメント糸が、ISO11676に従って、以下の方式によって、1つはフル/3つは空の状態において通される。
バー3:3.4/0.0/2.1/5.5//.
棘は、次いで、第WO01/81667号に説明される方法に従って、バー3によって生成された重なりのループを融解することによって、生成される。
In this example, the patch 4 is made from a gripping fabric obtained in the following manner. The knitted fabric is generated on a 24-gauge flat knitting machine using three needle guide bars. Bars 1 and 2 are intended to form the body of a grippable fabric, with 0.09 mm diameter polyethylene terephthalate (PET) monofilament yarns according to ISO 11676, one full / one empty according to the following scheme: In the state of.
Bar 1: 1.0 / 0.1 //
Bar 2: 4.5 / 1.0 //.
Bar 3 is intended to form a monofilament overlap and result in barbs, 0.15 mm diameter polylactic acid (PLA) monofilament yarns according to ISO 11676, one full / three empty Threaded in state.
Bar 3: 3.4 / 0.0 / 2.1 / 5.5 //.
The barbs are then generated by melting the overlapping loop generated by bar 3 according to the method described in WO 01/81667.
把持性生地の両表面は、次いで、プラズマ増強化学蒸着(PECVD)によって、金でコーティングされる。 Both surfaces of the gripping fabric are then coated with gold by plasma enhanced chemical vapor deposition (PECVD).
次に、結果として生じるコーティングされた把持性生地は、4つのパッチに切断される。これらのパッチは、放射線撮影のための所望の放射線不透過性に応じて、面積、例えば、0.5から6cm2を有してもよい。 The resulting coated gripping fabric is then cut into four patches. These patches may have an area, for example 0.5 to 6 cm 2 depending on the desired radiopacity for radiography.
図3は、図1のキット1から生成される、本発明による、プロテーゼ10を示す。プロテーゼ10を生成するために、ベース生地片2の開口付き表面3に向かって指向された棘5を伴う、4つのパッチ4が、単に、適用され、その上に圧力が付与された。4つのパッチ4は、外科医が、プロテーゼが埋め込まれると、放射線透視によって、プロテーゼの位置を容易に判定することができるように、ベース生地の開口付き表面3上の具体的場所、すなわち、それぞれ、ベース生地2の1つの隅に適用された。患者の身体内のプロテーゼ10の位置は、したがって、埋込から数週間または数カ月後、確認されてもよい。
FIG. 3 shows a
プロテーゼ10は、上で述べたように、単純および特に迅速に、生成された。特に、埋込直後、外科医自身によって、容易に生成されてもよい。
例証されない実施形態では、4つのパッチはそれぞれ、外科医が、プロテーゼのどの隅が、どの場所に位置付けられるかを正確に判定し得るように、特定の形状、例えば、円形、十字、三角形等を画定する、放射線不透過性材料から作製される、糸を備えてもよい。 In an unillustrated embodiment, each of the four patches defines a specific shape, such as a circle, a cross, a triangle, etc., so that the surgeon can accurately determine which corner of the prosthesis is located at which location. A yarn made from a radiopaque material may be provided.
Claims (12)
少なくとも1つのパッチ(4)であって、その表面のうちの1つから突出し、少なくとも1つの放射線不透過性要素を備える、少なくとも1つの棘(5)を具備し、前記棘または複数の棘は、前記表面上の具体的場所において、前記パッチを前記ベース生地の開口付き表面に把持するように締結するように設計される、パッチと
を備え、前記パッチは、把持性生地から作製されることを特徴とする、キット(1)。 At least one base fabric (2) having at least one open surface (3) designed to be implanted in an implantation site;
At least one patch (4) comprising at least one barb (5) protruding from one of its surfaces and comprising at least one radiopaque element, said barb or spines being A patch designed to fasten the patch to a gripped surface of the base fabric at a specific location on the surface, the patch being made from a gripping fabric A kit (1) characterized in that
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FR1055798A FR2962646B1 (en) | 2010-07-16 | 2010-07-16 | PROSTHETIC WITH RADIO OPAQUE ELEMENT |
FR10/55798 | 2010-07-16 | ||
PCT/EP2011/062148 WO2012007579A1 (en) | 2010-07-16 | 2011-07-15 | Prosthesis having a radiopaque element |
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JP2013535245A JP2013535245A (en) | 2013-09-12 |
JP5896538B2 true JP5896538B2 (en) | 2016-03-30 |
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JP2013519113A Active JP5896538B2 (en) | 2010-07-16 | 2011-07-15 | Prosthesis with radiopaque elements |
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US (1) | US10076395B2 (en) |
EP (1) | EP2593037B1 (en) |
JP (1) | JP5896538B2 (en) |
CN (1) | CN103079496B (en) |
AU (1) | AU2011278230B2 (en) |
CA (1) | CA2805497C (en) |
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CA2805497C (en) | 2018-08-07 |
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CN103079496B (en) | 2016-01-20 |
US20130158572A1 (en) | 2013-06-20 |
US10076395B2 (en) | 2018-09-18 |
JP2013535245A (en) | 2013-09-12 |
WO2012007579A1 (en) | 2012-01-19 |
AU2011278230A1 (en) | 2013-01-31 |
FR2962646A1 (en) | 2012-01-20 |
CN103079496A (en) | 2013-05-01 |
AU2011278230B2 (en) | 2015-08-27 |
CA2805497A1 (en) | 2012-01-19 |
EP2593037B1 (en) | 2014-03-26 |
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